FDA declines approval of needle-free EpiPen alternative, wants more data

The Food and Drug Administration has refused to approve an epinephrine nasal spray that would have been the first needle-free alternative to the EpiPen, according to the manufacturer.

Instead, ARS Pharmaceuticals announced late Tuesday that the FDA is requiring more research before approving its product, Niffy.

Epinephrine has been used since 1901 and is the first line of defense for treating allergic reactions, including anaphylaxis. However, like the well-known EpiPen and other auto-injectors, all current epinephrine treatments use needles, which poses a problem for people with needle phobia.

The denial comes after the agency’s advisory committee told the FDA in May that it should be used for children and adults suffering from severe allergic reactions without the need for additional research to prove its effectiveness or safety. This was despite recommendations to approve the product.

“We are extremely surprised by this action,” said Richard Lowenthal, president and CEO of ARS Pharmaceuticals. He said the FDA requires the company to conduct multiple-dose studies before approval, which would have been required after marketing.

The FDA wants a study to compare repeated doses of Nephy with repeated doses of epinephrine injections in people with allergen-induced symptoms such as sneezing, itching, and stuffy noses.

“We deeply regret that this action will further delay the availability of Nephi to millions of people who are at risk of severe, life-threatening allergic reactions. ” Lowenthal said. “Patients and caregivers are waiting for Nephi, and we aim to complete the newly requested trials as quickly as possible to meet the needs of our patients.”

Part of the appeal of the Neffy, in addition to eliminating the need for needles, was that it competed with the more expensive EpiPen.

In 2007, a pack of two injectors cost $100, but by 2016, each pen cost a fraction of the cost to produce when Mylan purchased the product. The price has increased to more than $600.

As a result of the outcry, Mylan began selling “certified generics” for $300. Authorized generics are essentially the same product as the branded drug, only sold as a generic.

Mylan eventually merged with a division of Pfizer to form Vitalis, the current maker of the EpiPen.

In May, an FDA advisory committee voted 16-6 in favor of the drug for adults and 17-5 in favor of the drug for children to treat severe allergic reactions, including anaphylaxis.

But the agency was concerned about the lack of clinical data, despite the product’s potential to save lives.

Rather than conduct large-scale clinical trials, the manufacturer compared its product to already approved injectable epinephrine products. No studies have been conducted on people experiencing anaphylaxis.

Lowenthal said the company plans to file a dispute resolution request with the FDA to appeal the request for additional trials, and expects to resubmit to the FDA in the first half of 2024, with approval expected by the end of next year. He said he expected that.